A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age

Trial Profile

A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Nov 2017

At a glance

  • Drugs V 270 (Primary) ; Hepatitis B vaccine recombinant
  • Indications Hepatitis B
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Dynavax Technologies
  • Most Recent Events

    • 09 Nov 2017 According to a Dynavax Technologies media release, the U.S. Food and Drug Administration (FDA) has approved HEPLISAV-B for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
    • 03 Apr 2017 According to a Dynavax Technologies media release, the U.S. Food and Drug Administration (FDA) has informed the company that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review HEPLISAV-B™ at its meeting scheduled for July 28, 2017. The scheduled VRBPAC meeting is close to the HEPLISAV-B Prescription Drug User Fee Act date of August 10, 2017 solely as a function of meeting logistics. The PDUFA date remains unchanged.
    • 26 Oct 2016 Sub-group results published in the Dynavax Media Release.
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